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Recall Observatory FDA recall evidence

Device product

Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only

Z-2076-2021

May 14, 2021

Class II

Product summary

Firm
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Event
Event 88089
Status
Ongoing
Classification
Class II
Quantity
21,685
Official record key
device-enforcement:Z-2076-2021

Official wording

Reason: Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.

Code information: Model Number: LNQ22

Distribution pattern: Worldwide distribution - US Nationwide in the states of AK, AL, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY. The countries of Australia, Austria, Canada, Denmark, Finland, Germany, Ireland, Italy, Netherlands, Netherlands Antilles, Sweden, Switzerland, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.